Drug Facts

Drug Facts
SPL v13
SPL
SPL Set ID 7b74ea7b-9dc0-435e-80ce-8d48b3bef615
Route
TOPICAL
Published
Effective Date 2020-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.0062 g)
Inactive Ingredients
Water Glycerin Polysorbate 20 Phenoxyethanol Sodium Benzoate Citric Acid Monohydrate Potassium Sorbate Ethylhexylglycerin Decyl Glucoside .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-04

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Uses
  • For hand sanitizing to decrease bacteria on the skin.
  • Apply topically to the skin to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.
Warnings
  • For external use only
  • May irritate eyes
Directions
  • Remove lid and discard seal from container
  • Pull wipe from center of roll and thread through opening in lid. Do not push finger through opening.
  • Replace lid, pull wipe up, and the out at 45° angle. The next wipe dispenses automatically
  • Close lid to retain moisture

OR

  • Tear V notch on top of plastic bag
  • Pull first wipe from the center of roll through opening of bag
  • Thread first-wipe through the dispensing noozle in lid of floor stand or
  • Thread first-wipe through the dispensing noozle in top of wall mounted dispenser
  • Close dispenser door, Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients

Water (Aqua), Glycerin, Polysorbate 20, Phenoxyethanol, Sodium Benzoate, Citric Acid, Potassium Sorbate, Fragrance, Ethylhexylglycerin, Decyl Glucoside, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

NDC 67151-303-01

WIPES PLUS ®

Re-Order / Item No. 37503

80 CT PRE_MOISTENED TOWELETTES

6.3" X 6.7" (16 cm X 17.01 cm)

NDC 67151-303-04

WIPES PLUS ®

HAND SANITIZING

ALCOHOL FREE WIPES

LEMON SCENT

KILLS 99.9% OF GERMS

240 PRE-MOISTENED TOWELETTES

6' X 6.75' (15.2 cm X 17.1 cm)

PROGRESSIVE PRODUCTS, LLC

4 International Drive, Rye Brook, NY 10573

Call 914-4176022

Re-Order / item No. 33803

www.wipesplus.com

NDC 67151-303-07

WIPES PLUS ®

SANITIZING

ALCOHOL FREE WIPES

LEMON SCENT

KILLS 99.9% OF GERMS in 15 SECONDS

800 PRE-MOISTENED TOWELETTES

8" X 6" (20.3 cm X 15.2 cm)

SEE BACK PANEL FOR ADDITONAL PRECAUTIONARY STATEMENTS

NOT A BABY WIPE

PROGRESSIVE PRODUCTS, LLC

4 International Drive, Rye Brook, NY 10573

Call 914-4176022

Re-Order / item No. 33803

www.wipesplus.com

NDC 67151-303-08

WIPES PLUS ®

SANITIZING

ALCOHOL FREE WIPES

LEMON SCENT

KILLS 99.9% OF GERMS in 15 SECONDS

1200 PRE-MOISTENED TOWELETTES

8" X 5" (20.32 cm X 12.7 cm)

SEE BACK PANEL FOR ADDITONAL PRECAUTIONARY STATEMENTS

NOT A BABY WIPE

PROGRESSIVE PRODUCTS, LLC

4 International Drive, Rye Brook, NY 10573

Call 914-4176022

Re-Order / item No. 33803

www.wipesplus.com

NDC 67151-303-09

WIPES PLUS ®

Re-Order / Item No. 37502

1500 CT

Keep Our of Reach of Children

Keep out of reach of children unless under adult supervision


Structured Label Content

Uses
  • For hand sanitizing to decrease bacteria on the skin.
  • Apply topically to the skin to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.
Purpose

Antiseptic

Warnings
  • For external use only
  • May irritate eyes
Directions
  • Remove lid and discard seal from container
  • Pull wipe from center of roll and thread through opening in lid. Do not push finger through opening.
  • Replace lid, pull wipe up, and the out at 45° angle. The next wipe dispenses automatically
  • Close lid to retain moisture

OR

  • Tear V notch on top of plastic bag
  • Pull first wipe from the center of roll through opening of bag
  • Thread first-wipe through the dispensing noozle in lid of floor stand or
  • Thread first-wipe through the dispensing noozle in top of wall mounted dispenser
  • Close dispenser door, Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

Active Ingredient

Benzalkonium chloride 0.13%

Inactive Ingredients

Water (Aqua), Glycerin, Polysorbate 20, Phenoxyethanol, Sodium Benzoate, Citric Acid, Potassium Sorbate, Fragrance, Ethylhexylglycerin, Decyl Glucoside, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

NDC 67151-303-01

WIPES PLUS ®

Re-Order / Item No. 37503

80 CT PRE_MOISTENED TOWELETTES

6.3" X 6.7" (16 cm X 17.01 cm)

NDC 67151-303-04

WIPES PLUS ®

HAND SANITIZING

ALCOHOL FREE WIPES

LEMON SCENT

KILLS 99.9% OF GERMS

240 PRE-MOISTENED TOWELETTES

6' X 6.75' (15.2 cm X 17.1 cm)

PROGRESSIVE PRODUCTS, LLC

4 International Drive, Rye Brook, NY 10573

Call 914-4176022

Re-Order / item No. 33803

www.wipesplus.com

NDC 67151-303-07

WIPES PLUS ®

SANITIZING

ALCOHOL FREE WIPES

LEMON SCENT

KILLS 99.9% OF GERMS in 15 SECONDS

800 PRE-MOISTENED TOWELETTES

8" X 6" (20.3 cm X 15.2 cm)

SEE BACK PANEL FOR ADDITONAL PRECAUTIONARY STATEMENTS

NOT A BABY WIPE

PROGRESSIVE PRODUCTS, LLC

4 International Drive, Rye Brook, NY 10573

Call 914-4176022

Re-Order / item No. 33803

www.wipesplus.com

NDC 67151-303-08

WIPES PLUS ®

SANITIZING

ALCOHOL FREE WIPES

LEMON SCENT

KILLS 99.9% OF GERMS in 15 SECONDS

1200 PRE-MOISTENED TOWELETTES

8" X 5" (20.32 cm X 12.7 cm)

SEE BACK PANEL FOR ADDITONAL PRECAUTIONARY STATEMENTS

NOT A BABY WIPE

PROGRESSIVE PRODUCTS, LLC

4 International Drive, Rye Brook, NY 10573

Call 914-4176022

Re-Order / item No. 33803

www.wipesplus.com

NDC 67151-303-09

WIPES PLUS ®

Re-Order / Item No. 37502

1500 CT

Keep Our of Reach of Children (Keep our of reach of children)

Keep out of reach of children unless under adult supervision


Advanced Ingredient Data


Raw Label Data

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